- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02398383
Role of Glucagon In Glucose Control in Cystic Fibrosis Related Diabetes
Role of Glucagon in Glucose Control in Cystic Fibrosis Related Diabetes
Přehled studie
Postavení
Detailní popis
This project is designed to begin to characterize the abnormalities of glucagon secretion in subjects with cystic fibrosis related diabetes along the spectrum of glucose tolerance. This will be a descriptive, cross-sectional and longitudinal cohort study in a sample of children and young adults with CF and a continuum of glucose tolerance compared to healthy age-matched controls.
Cystic fibrosis patients with normal glucose tolerance as well as cystic fibrosis related diabetes as well as control subjects will be admitted to the research unit on three separate occasions to undergo an oral glucose tolerance test, mixed meal tolerance test, and one step hypoglycemic clamp. Cystic fibrosis patients will then return 12 months later to undergo repeat mixed meal tolerance test and hypoglycemic clamp test.
Typ studie
Zápis (Aktuální)
Fáze
- Raná fáze 1
Kontakty a umístění
Studijní místa
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Connecticut
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New Haven, Connecticut, Spojené státy, 06511
- Yale New Haven Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Diagnosis of CF by clinical or genetic determination
- Normal glucose tolerance or CFRD
- Subjects routinely taking systemic or inhaled glucocorticoids on stable regimen are eligible
Exclusion Criteria:
- Subjects with active pulmonary infection requiring supplemental doses of corticosteroids
- Use of any oral diabetes medications
- Subjects who are pregnant/lactating
- Subjects with poor compliance with pancreatic enzyme replacement therapy
Control Subjects:
Approximately 10 control subjects who are matched for age, gender, are expected to be enrolled in the study. Non-CF subjects must be >12 years old, in good health and not taking any medications or have any medical problems the doctor feels would prevent the subject from completing the study and have BMI between 15-85% for age and gender. Control subjects whose fasting blood glucose is found to be >110 mg/dL will not be continued in the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Základní věda
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: CF with Normal Glucose Tolerance
Individuals with CF without cystic fibrosis related diabetes
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Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm.
Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes.
Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml.
Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
All subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose.
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Experimentální: Cystic Fibrosis Related Diabetes
Individuals with cystic fibrosis and cystic fibrosis related diabetes
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Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm.
Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes.
Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml.
Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
All subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose.
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Aktivní komparátor: Control
Age matched control subjects
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Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm.
Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes.
Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling.
Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml.
Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
All subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp.
Subjects will be instructed to fast after midnight the night prior to the study.
Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Glucagon levels
Časové okno: baseline
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Glucagon levels in response to to a mixed meal stimulus
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baseline
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
C-peptide levels
Časové okno: baseline
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C-peptide levels during oral glucose tolerance test and mixed meal tolerance test
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baseline
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C-peptide levels
Časové okno: 12 months
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C-peptide levels during oral glucose tolerance test and mixed meal tolerance test
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12 months
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Epinephrine levels
Časové okno: baseline
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Epinephrine and norepinephrine levels during hypoglycemic clamp
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baseline
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Epinephrine levels
Časové okno: 12 months
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Epinephrine and norepinephrine levels during hypoglycemic clamp
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12 months
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Norepinephrine levels
Časové okno: baseline
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norepinephrine levels during hypoglycemic clamp
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baseline
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Norepinephrine levels
Časové okno: 12 months
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norepinephrine levels during hypoglycemic clamp
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12 months
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Hypoglycemia unawareness scores
Časové okno: Baseline
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Hypoglycemia unawareness scores in subjects during hypoglycemic clamps as measured by the Clarke Hypoglycemia Awareness survey
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Baseline
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Hypoglycemia unawareness scores
Časové okno: 12 months
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Hypoglycemia unawareness scores in subjects during hypoglycemic clamps as measured by the Clarke Hypoglycemia Awareness survey
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12 months
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GLP-1 and GIP levels
Časové okno: Baseline
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GLP-1 and GIP levels in response to mixed meal stimulus
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Baseline
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GLP-1 and GIP levels
Časové okno: 12 months
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GLP-1 and GIP levels in response to mixed meal stimulus
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12 months
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Glucagon levels
Časové okno: 12 months
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Glucagon levels in response to to a mixed meal stimulus and difference from baseline
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12 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Bracha Goldsweig, MD, Yale University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Nemoci trávicího systému
- Patologické procesy
- Poruchy metabolismu glukózy
- Metabolické choroby
- Nemoci dýchacích cest
- Plicní onemocnění
- Onemocnění endokrinního systému
- Kojenec, novorozenec, nemoci
- Genetické choroby, vrozené
- Onemocnění slinivky břišní
- Fibróza
- Diabetes Mellitus
- Cystická fibróza
- Fyziologické účinky léků
- Hypoglykemická činidla
Další identifikační čísla studie
- 1409014580
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